Method of treating pediatric patients with corticosteroids

Abstract

The present invention comprises a method of treating pediatric patients suffering from an inflammatory or pruritic skin disorder comprising topically applying fluocinonide to an affected area. Treatment according to this method does not result in clinically significant suppression of the HPA-axis.

Description

FIELD OF THE INVENTION [0001] Clinically, topical corticosteroids are useful for their anti-inflammatory, and anti-pruritic actions. Corticosteroids (or corticoids) are any steroids (lipids that contain a hydrogenated cyclopentoperhydrophenanthrene ring system) elaborated by the adrenal cortex (except sex hormones of adrenal origin) in response to the release of adrenocorticotrophin or adrenocorticotropic hormone by the pituitary gland, or to any synthetic equivalent, or to angiotensin II. [0002] The potency of topical steroid preparations is strongly correlated to their absorption through the skin and activity of the compound. Treatment of the skin prior to application of the topical steroid may also affect the absorption of the compounds into the skin. Treatments with keratolytics or with fat solvents (such as acetone) disrupt the epidermal barrier and increase penetration. Hydrating the skin has also been shown to increase the penetration of the corticosteroids. [0003] Once absor...

AI Technical Summary

Benefits of technology

[0017] According to the present invention, a class I steroid, such as fluocinonide, may be safely administered topically to pediatric patients once or twice daily, with little or no suppression of the HPA-axis. Fluocinonide compositions may be formulated at various potencies depending on the vehicle used and the amount of fluocinonide added to the composition. Fluocinonide (0.1% cream), formulated as a class I steroid, administered once daily does not result in suppression of the HPA-axis in patients 3 months to <18 years of age. Fluocinonide (0.1% cream), formulated as a Class I steroid, administered twice daily may be responsible for a low incidence of suppression of the HPA-axis. Fluocinonide 0.1%, formulated as a Class I steroid, administered once or twice daily is safe, as measured by serum cortisol levels before and after cosyntropin stimulation, evaluation of adverse events, signs and symptoms of skin disease, and vital signs measurements in atopic dermatitis patients 3 months to <18 years of age.

Problems solved by technology

Pediatric patients may be more susceptible to systemic toxicity from the use of topical steroids because of their larger skin surface to body mass ratios.

The use of topical steroids in pediatric patients has resulted in adverse effects including striae, HPA-axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension.